INI-001 will be conducted at more than 30 centers in the US and led by co-principal investigators Ramaswamy Govindan, MD, Anheuser-Busch Endowed Chair in Medical Oncology, Director, Section of Oncology, Washington University School of Medicine and Ed Kim, MD, Chairman, Solid Tumor Oncology and Investigational Therapeutics at Levine Cancer Institute. It is expected to recruit several hundred patients. It is a prospective study to evaluate the performance of Inivata’s targeted molecular profiling liquid biopsy platform in comparison to tissue based molecular profiling in patients with advanced NSCLC.

Inivata has selected Vector Oncology as the Clinical Research Organization for the study. Patient samples will be analyzed at Inivata’s recently opened CLIA-accredited laboratory in Research Triangle Park, North Carolina. “Liquid biopsy approaches allow for far less invasive analysis of a patient’s cancer and have the potential to greatly improve care. This is an important, rigorously-designed trial and we look forward to working with Inivata and the study centers to advance the understanding of ctDNA analysis in a clinical setting,” said Lee Schwartzberg, MD, President and Chief Medical Officer of Vector Oncology.

“Tissue biopsies are highly invasive, particularly in lung cancer, and can fail as a result of lack of tissue availability. The launch of this trial is an exciting step in establishing the clinical utility of liquid biopsies in a disease which remains a significant cause of cancer-related mortality,” said Dr. Govindan. Dr. Kim added, “I am excited to see Inivata take this important step to begin to establish a robust clinical evidence base for their novel approach to ctDNA analysis. The potential of ctDNA to unlock real time genomic information to help us treat lung cancer patients more effectively has transformative potential, and I am eager to work with the strong scientific and medical teams at Inivata to demonstrate the clinical utility of these approaches over time.”

Inivata is currently involved with a number of clinical studies with leading cancer centers globally, but this is Inivata’s first prospective clinical validation study. Clive Morris, MD, Inivata’s Chief Medical Officer said, “We are thrilled to partner with outstanding national cancer centers across the US to launch our INI-001 study, which will correlate our highly sensitive ctDNA analysis from a simple blood draw with standard of care tissue biopsies. These data will be a key part of the evidence to support the use of Inivata’s proprietary platform in helping physicians improve the clinical outcomes of their cancer patients.”

The INI-001 (NCT02906852) trial is expected to complete in July 2017. The primary outcome measure is concordance in the detection of molecular abnormalities using Inivata’s liquid biopsy panel with detection using standard of care tissue biopsy analysis. Secondary outcome measures include sensitivity and specificity comparisons, and an analysis of the proportion of NSCLC patients eligible for targeted therapy compared to standard of care alone. More details can be seen at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02906852?term=inivata&rank=1).

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What is Exosome RNA?

Exosomes are cell-derived vesicles that are present in many and perhaps all biological fluids, including blood, urine, and cultured medium of cell cultures. Exosomes contain various molecular constituents of their cell of origin, including proteins and RNA. It is becoming increasingly clear that exosomes have specialized functions and play a key role in, for example, coagulation, intercellular signaling, and waste management. - from wikipedia